PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Perioperative Percutaneous Electrical Nerve Stimulation Via a Wearable Equipment on Postoperative Nausea and Vomiting（PONV） in Patients Undergoing Laparoscopy Abdominal Surgery: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241547
• Other study ID #: I-23PJ1712
• Status: Recruiting
• Phase: Phase 2
• Start date: January 12, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Chen Junjie
• Phone: +8617330860407
• Email: 1045034956[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

Description:

Introduction: This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting. Method and analysis: A total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. Participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. The electrical stimulation group will receive PC point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. The primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18-65 years;

2. Patients undergoing elective laparoscopic surgery;

3. American Society of Anaesthesiologists(ASA) Grade 1 to 3;

4. Anesthesia: General Anesthesia, Tracheal Intubation;

5. BMI: =18, <28;

6. Gender: female

7. Patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent.

Exclusion Criteria:

1. There are incisions or scars in the wearing position of the device;

2. There is a local infection in the wearing position of the device;

3. upper extremity nerve injury;

4. history of spinal cord surgery;

5. Participated in other clinical trials within 4 weeks;

6. suffering from severe central nervous system disease or mental disorder;

7. Patients need to return to the ICU after surgery.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• electrical stimualtion via EmeTerm bracelet
We planned to exert electrical stimulation via the bracelet.

Drug:
• antimetic drugs( dexamethasone,ondansetron)
Antimetic drugs (dexamethasone ondansetron) are used to prevent postoperative nausea and vomiting.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting(PONV)	Ask patients if they experienced nausea or vomiting 24 hours after surgery.	24 hours after surgery